Illustrative composite — not a real study. The Study Record shown on this page is a hypothetical example built to demonstrate how to complete the human-subjects portion of NIH’s Human Subjects and Clinical Trials Information (HSCTI) form, not a real funded project. Titles, participant figures, and narrative text are invented for illustration. Always write your own Study Record from your actual protocol and consult your institution’s IRB and sponsored-programs office before submission — see PHS Human Subjects and Clinical Trials Information Form: What It Requires and When It’s Triggered for the full structural reference this worked example follows.
What this walkthrough covers
The HSCTI form’s human-subjects layer applies to every Study Record involving human participants, regardless of whether that study also meets NIH’s clinical-trial definition. This page works through one hypothetical Study Record — a single-site observational cohort study that involves human subjects but does not meet NIH’s four-question clinical-trial test (no prospective assignment to an intervention) — so the fields below are the ones every human-subjects applicant completes, without the additional clinical-trial-specific sections (study design, protocol synopsis, timeline, data and safety monitoring plan sized to trial risk) covered separately in the companion guide linked above. If your study does meet the clinical-trial definition, plan on completing both layers for that Study Record.
Illustrative Study Record: “Biomarkers of Post-Surgical Recovery in Adults Undergoing Elective Knee Arthroplasty”
The fictional example below is one Study Record within a larger, invented NIH R01 application. Field labels follow the structure NIH’s form guidance uses; actual field names and ordering can shift slightly between forms packages (FORMS-H vs. FORMS-I), so treat the labels as illustrative of content, not a literal copy of the current PDF layout.
Study title and general information
- Study title: “Biomarkers of Post-Surgical Recovery in Adults Undergoing Elective Knee Arthroplasty” (invented example)
- Are human subjects involved? Yes
- Human subjects study status: New study — no existing NIH-assigned study identifier
- Does this study meet NIH’s definition of a clinical trial? No — the study is observational; investigators collect blood samples and administer validated recovery questionnaires but do not assign participants to an intervention or comparator as part of the research
Study population characteristics
This is the section reviewers use to understand exactly who will be enrolled and why that population is appropriate for the research question. A thin restatement of the eligibility criteria without rationale is a common weakness reviewers flag; the example below pairs each criterion with the reason it exists.
- Illustrative inclusion criteria: Adults aged 45–80 years; scheduled for primary unilateral elective total knee arthroplasty at the study site; able to provide written informed consent in English or Spanish; willing to complete follow-up assessments through 12 weeks post-surgery.
- Illustrative exclusion criteria: Prior arthroplasty of the contralateral knee within the past 12 months; diagnosed inflammatory arthritis (to isolate osteoarthritis-driven recovery biomarkers from an inflammatory-disease confound); active malignancy; cognitive impairment precluding informed consent or self-reported outcome completion.
- Illustrative rationale text: “The age range reflects the population in which elective knee arthroplasty is most commonly performed at the study site based on prior-year surgical volume. Participants with inflammatory arthritis are excluded because the biomarker panel under study is intended to characterize recovery trajectories specific to osteoarthritis-driven joint degeneration; including an inflammatory-arthritis subgroup would confound the primary biomarker analysis without a sample size sufficient to analyze it as a separate stratum.”
Inclusion of women, minorities, and children (Inclusion Enrollment Report)
NIH requires a planned-enrollment table broken out by sex/gender and race/ethnicity, plus narrative addressing children. The illustrative placeholder numbers below show the shape of that table — real applications populate it with figures the investigator can justify from the study’s power calculation and the demographic composition of the eligible population at the site, not round numbers chosen for convenience.
| Category | Illustrative planned enrollment |
|---|---|
| Total planned enrollment | 120 participants |
| Sex/gender — female | 66 (55%, illustrative) |
| Sex/gender — male | 54 (45%, illustrative) |
| Race/ethnicity breakdown | Populated to reflect the site’s actual surgical-population demographics — placeholder only, do not copy these proportions into a real submission |
- Illustrative children narrative: “Children (individuals under age 18) are excluded. Elective total knee arthroplasty in this age range is exceedingly rare and not representative of the population this study is designed to characterize; excluding children does not compromise generalizability of the study’s aims.”
Recruitment and retention plan
This narrative should describe where participants come from, how they are approached, and what the study does to keep enrolled participants through the full follow-up period — reviewers read this section for feasibility, not just ethics.
Illustrative example text: “Participants will be identified from the surgical scheduling system by the study coordinator, who will screen the upcoming elective-arthroplasty schedule against eligibility criteria on a rolling weekly basis. Eligible patients will be approached in person at their pre-operative clinic visit, given the consent form to review, and offered at least 24 hours before being asked to enroll to reduce time pressure on the consent decision. To support retention through the 12-week follow-up window, participants will receive a $25 gift card for each completed follow-up visit (at 2, 6, and 12 weeks), study visits will be scheduled to coincide with already-planned post-surgical clinic appointments where possible, and the coordinator will send a reminder call or message 48 hours before each visit.”
Protection of human subjects from research risks
NIH expects this section to walk through actual anticipated risks — physical, psychological, social, or informational — and the specific steps taken to minimize each one, not a generic statement that the study is low-risk.
Illustrative example text: “The primary research-related risk is the discomfort and small bruising/bleeding risk associated with venous blood draw for biomarker analysis, which will be performed by trained clinical staff using standard phlebotomy technique. Recovery-questionnaire items ask about pain and mood, which carries a minor psychological-discomfort risk; participants may decline to answer any item without penalty. Because the dataset will include protected health information linked to surgical outcomes, the primary non-physical risk is a breach of confidentiality; data will be de-identified at the point of analysis, stored on the institution’s IRB-approved secure server, and the linkage key will be retained separately by the coordinator only for the duration needed to complete follow-up assessments.”
Data and safety monitoring for risk level
Even a study that does not meet NIH’s clinical-trial definition needs monitoring arrangements sized to its actual risk level — this does not require a formal Data Safety Monitoring Board for a minimal-risk observational study, but the plan should say so explicitly rather than leaving the question unaddressed.
Illustrative example text: “Given the minimal-risk nature of this observational study (routine blood draw and validated questionnaires, no experimental intervention), a formal Data Safety Monitoring Board is not proposed. The principal investigator will review adverse-event and protocol-deviation logs monthly and report any unanticipated problems involving risk to participants to the IRB per institutional policy and timelines.”
Where the clinical-trial-specific sections would attach
If the hypothetical study above had instead randomized participants to two different post-surgical rehabilitation protocols and measured recovery as the outcome, it would meet NIH’s four-question clinical-trial test (human participants, prospective assignment to an intervention, a design intended to evaluate the intervention’s effect, a health-related outcome), and the same Study Record would additionally require the clinical-trial-specific sections — study design (arms, comparator, outcome measures), a protocol synopsis, a study timeline, and a data and safety monitoring plan scaled to the trial’s actual risk level. See What Is a Clinical Trial? The NIH Definition Explained for the full four-question test, and the companion PHS Human Subjects and Clinical Trials Information Form guide for what those additional sections require.
Common mistakes reviewers flag
- Restating eligibility criteria without rationale. Reviewers want to know why each criterion exists, not just what it is — as in the illustrative rationale text above.
- Duplicating Study Record content in the Research Strategy attachment. NIH guidance is explicit that study-level human-subjects detail belongs in the HSCTI form; the Research Strategy should reference it rather than restate it at length.
- Leaving the Inclusion Enrollment Report as a placeholder. Planned-enrollment figures need to be defensible from the site’s actual eligible population and the study’s power calculation, not filled in with round numbers late in preparation.
- Treating “minimal risk” as requiring no monitoring narrative. Even a minimal-risk, non-trial study needs an explicit (if brief) statement of how adverse events and unanticipated problems will be reviewed and reported — an empty section reads as an oversight, not as “not applicable.”
- Building one Study Record for a multi-study application. A Study Record corresponds to a distinct study, not necessarily to a specific aim; an application spanning several distinct studies typically needs a separate Study Record for each.
Frequently asked questions
Is this a real NIH-funded study?
No. The Study Record on this page is an invented, illustrative composite built to show the shape and level of detail NIH’s Human Subjects and Clinical Trials Information form expects — not a real funded project, and not a template to copy field-for-field into an actual submission.
Do I need the clinical-trial-specific sections for a study like this?
Only if your specific study meets NIH’s four-question clinical-trial definition (human participants, prospective assignment to an intervention, a design meant to evaluate that intervention’s effect, and a health-related outcome as the effect being measured). The observational example above does not meet that definition, so it completes only the human-subjects layer of the form. See What Is a Clinical Trial? The NIH Definition Explained to check your own study against the test.
How detailed does the real Inclusion Enrollment Report need to be?
NIH expects planned-enrollment figures broken out by sex/gender and race/ethnicity that are defensible from your actual power calculation and the demographic composition of your eligible population — not the round placeholder numbers used for illustration above. Coordinate with your biostatistician on these figures early rather than filling them in at the last minute.
Where do I find NIH’s actual form and current field requirements?
Confirm current field-level requirements directly against grants.nih.gov and the specific funding opportunity announcement’s forms package (FORMS-H or FORMS-I) before finalizing a real Study Record — see the PHS Human Subjects and Clinical Trials Information Form guide for the forms-package timeline and structural reference.
Related CASRAI resources
- PHS Human Subjects and Clinical Trials Information Form: What It Requires and When It’s Triggered — the structural reference this worked example follows.
- What Is a Clinical Trial? The NIH Definition Explained — the four-question test referenced above.
- Exempt Human Subjects Research — for studies that may not require the fuller human-subjects sections at all.
- Informed Consent Checklist for Researchers — background for the consent process referenced in the recruitment plan above.
- NIH Research Strategy: Significance, Innovation, Approach (With a Worked Example) — the companion attachment that should reference, not restate, the Study Record content shown here.
Primary source: NIH’s Human Subjects and Clinical Trials Information form guidance and the FORMS-I application guide, published at grants.nih.gov. Field labels and structure in this walkthrough reflect the form’s general organization as described in NIH guidance and cross-referenced against CASRAI’s own structural guide to the form (linked above); the specific study, participant figures, and narrative text on this page are entirely invented for illustration and should not be copied into a real submission.
